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Postoperatively Treated Patients With Lower Limb Fracture With or Without an Anti-gravity Treadmill

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ClinicalTrials.gov Identifier: NCT02790229
Recruitment Status : Completed
First Posted : June 3, 2016
Last Update Posted : June 20, 2019
Sponsor:
Collaborators:
Ambulantes Reha Centrum Gruppe, Germany
Hospital St.Georg gGmbH; Clinic of Trauma, Orthopedic and septic Surgery, Leipzig, Germany
Information provided by (Responsible Party):
Dr. med. Ralf Henkelmann, University of Leipzig

Brief Summary:
The presented study is designed to prove efficacy of the anti-gravity treadmill (alter G®) compared to a standard rehabilitation protocol in patients with tibial plateau or ankle fractures with six weeks of partial weight bearing.

Condition or disease Intervention/treatment Phase
Muscle Degeneration Other: anti-gravity treadmill (alter G®) Other: standardized physiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outcome of Patients After Lower Limb Fracture With Partial Weight Bearing Postoperatively Treated With or Without Anti-gravity Treadmill (Alter G®) During Six Weeks of Rehabilitation - a Bicentric Prospective Randomized Trial
Study Start Date : August 2016
Actual Primary Completion Date : June 17, 2019
Actual Study Completion Date : June 17, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: anti-gravity treadmill arm
Treatment with anti-gravity treadmill (alter G®)
Other: anti-gravity treadmill (alter G®)
Patients in the experimental arm will be treated with manual lymphatic drainage, cryotherapy and a fixed protocol of training in an anti-gravity treadmill (alter G®). The protocol is designed parallel to standard physiotherapy with a frequency of two to three times a week with duration of about 20 minutes for six weeks.

control arm
Treatment with standardized physiotherapy
Other: standardized physiotherapy
Patients in the control arm will be treated with manual lymphatic drainage, cryotherapy and 20 minutes of physiotherapy two to three times a week for six weeks. Physiotherapy will be done according to a standardized protocol.




Primary Outcome Measures :
  1. Change of overall KOOS or FOAS [ Time Frame: 12 months ]
    Change of overall KOOS (Knee Injury and Osteoarthritis Outcome Score) or FOAS (Foot and Ankle Outcome Score) from baseline (Day 1 after operation) to Final Assessment (FA) 12 months after operation determined for each group and between the groups.


Secondary Outcome Measures :
  1. Change of the 5 subscores of the KOOS or FAOS [ Time Frame: Baseline to 6 and 12 weeks and 12 months ]
    Change of the 5 subscores of the KOOS or FAOS (Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec), knee/ankle related Quality of life (QoL)) determined for each group and between the groups.

  2. Circumference measurement of tights and lower leg on both legs [ Time Frame: Baseline to day of discharge, 3,6 and 12 weeks and 12 months ]
    Circumference measurement of tights and lower leg on both legs 10cm and 20cm above the knee joint space and 10cm below (knee in neutral position) from baseline (Day 1 after operation) to day of discharge (7-11d), 3, 6 and 12 weeks and 12 months (FA) after operation determined for each group and between the groups.

  3. ROM [ Time Frame: Baseline to 6 and 12 weeks and 12 months ]
    Range of motion (ROM) of the affected joint determined by neutral zero method from baseline (Day 1 after operation) to 6 and 12 weeks and 12 months after operation determined for each group and between the groups.

  4. SF-36 [ Time Frame: Baseline to 6 and 12 weeks and 12 months ]
    Short Form Health Survey (SF-36) from baseline (Day 1 after operation) to 6 and 12 weeks and 12 months after operation determined for each group and between the groups.

  5. DGI [ Time Frame: day of discharge to 3, 6 and 12 weeks and 12 months postoperative ]
    Dynamic gait index (DGI) from day of discharge (7-11d) to 3, 6 and 12 weeks and 12 months after operation determined for each group and between the groups.


Other Outcome Measures:
  1. Absence from work [ Time Frame: 12 months ]
    Number of days of absence from work (employment) and/or days of inability to follow usual activities until FA and time point when patient was back to work and/or to follow usual activities. Data recorded for each group and compared between the groups.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with a postoperative partial weight bearing after tibial plateau or ankle fracture.
  • man and woman of an age between 18 and 65

Exclusion Criteria:

  • Body weight more than 100kg
  • serious illness or poor general health as judged by physician that may influence the rehabilitation
  • open fractures (>1° according to Gustilo and Anderson)
  • surgical site infection
  • pregnancy
  • neuromuscular disorders or preexisting muscle atrophy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02790229


Locations
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Germany
University Leipzig, Clinic of Orthopedic, Trauma and Plastic Surgery
Leipzig, Saxony, Germany, 04103
Klinikum St. Georg gGmbH
Leipzig, Saxony, Germany, 04129
Sponsors and Collaborators
University of Leipzig
Ambulantes Reha Centrum Gruppe, Germany
Hospital St.Georg gGmbH; Clinic of Trauma, Orthopedic and septic Surgery, Leipzig, Germany
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. med. Ralf Henkelmann, University of Leipzig
ClinicalTrials.gov Identifier: NCT02790229    
Other Study ID Numbers: FR-0244
First Posted: June 3, 2016    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Dr. med. Ralf Henkelmann, University of Leipzig:
rehabilitation, anti-gravity treadmill